Everting Heart Valve

ABSTRACT

The present invention provides methods and apparatus for endovascularly replacing a patient&#39;s heart valve. The apparatus includes a replacement valve and an expandable anchor configured for endovascular delivery to a vicinity of the patient&#39;s heart valve. In some embodiments, the replacement valve is adapted to wrap about the anchor, for example, by everting during endovascular deployment. In some embodiments, the replacement valve is not connected to expandable portions of the anchor. In some embodiments, the anchor is configured for active foreshortening during endovascular deployment. In some embodiments, the anchor includes expandable lip and skirt regions for engaging the patient&#39;s heart valve during deployment. In some embodiments, the anchor comprises a braid fabricated from a single strand of wire. In some embodiments, the apparatus includes a lock configured to maintain anchor expansion. The invention also includes methods for endovascularly replacing a patient&#39;s heart valve. In some embodiments, the method includes the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve, wrapping at least a portion of the replacement valve about the anchor, and expanding the anchor to a deployed configuration.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of pending U.S. application Ser. No.10/870,340, filed Jun. 16, 2004, entitled “Everting Heart Valve”, thedisclosure of which is incorporated by reference in its entirety as iffully set forth herein.

BACKGROUND OF THE INVENTION

The present invention relates to methods and apparatus forendovascularly replacing a heart valve. More particularly, the presentinvention relates to methods and apparatus for endovascularly replacinga heart valve with a replacement valve and an expandable and retrievableanchor. The replacement valve preferably is not connected to theexpandable anchor and may be wrapped about an end of the anchor, forexample, by everting during endovascular deployment.

Heart valve surgery is used to repair or replace diseased heart valves.Valve surgery is an open-heart procedure conducted under generalanesthesia. An incision is made through the patient's sternum(sternotomy), and the patient's heart is stopped while blood flow isrerouted through a heart-lung bypass machine.

Valve replacement may be indicated when there is a narrowing of thenative heart valve, commonly referred to as stenosis, or when the nativevalve leaks or regurgitates. When replacing the valve, the native valveis excised and replaced with either a biologic or a mechanical valve.Mechanical valves require lifelong anticoagulant medication to preventblood clot formation, and clicking of the valve often may be heardthrough the chest. Biologic tissue valves typically do not require suchmedication. Tissue valves may be obtained from cadavers or may beporcine or bovine, and are commonly attached to synthetic rings that aresecured to the patient's heart.

Valve replacement surgery is a highly invasive operation withsignificant concomitant risk. Risks include bleeding, infection, stroke,heart attack, arrhythmia, renal failure, adverse reactions to theanesthesia medications, as well as sudden death. 2-5% of patients dieduring surgery.

Post-surgery, patients temporarily may be confused due to emboli andother factors associated with the heart-lung machine. The first 2-3 daysfollowing surgery are spent in an intensive care unit where heartfunctions can be closely monitored. The average hospital stay is between1 to 2 weeks, with several more weeks to months required for completerecovery.

In recent years, advancements in minimally invasive surgery andinterventional cardiology have encouraged some investigators to pursuepercutaneous replacement of the aortic heart valve. See, e.g., U.S. Pat.No. 6,168,614. In many of these procedures, the replacement valve isdeployed across the native diseased valve to permanently hold the valveopen, thereby alleviating a need to excise the native valve and toposition the replacement valve in place of the native valve.

In the endovascular aortic valve replacement procedure, accurateplacement of aortic valves relative to coronary ostia and the mitralvalve is critical. Standard self-expanding systems have very pooraccuracy in deployment, however. Often the proximal end of the stent isnot released from the delivery system until accurate placement isverified by fluoroscopy, and the stent typically jumps once released. Itis therefore often impossible to know where the ends of the stent willbe with respect to the native valve, the coronary ostia and the mitralvalve.

Also, visualization of the way the new valve is functioning prior tofinal deployment is very desirable. Visualization prior to final andirreversible deployment cannot be done with standard self-expandingsystems, however, and the replacement valve is often not fullyfunctional before final deployment.

Another drawback of prior art self-expanding replacement heart valvesystems is their lack of radial strength. In order for self-expandingsystems to be easily delivered through a delivery sheath, the metalneeds to flex and bend inside the delivery catheter without beingplastically deformed. In arterial stents, this is not a challenge, andthere are many commercial arterial stent systems that apply adequateradial force against the vessel wall and yet can collapse to a smallenough of a diameter to fit inside a delivery catheter without plasticdeformation. However when the stent has a valve fastened inside it, asis the case in aortic valve replacement, the anchoring of the stent tovessel walls is significantly challenged during diastole. The force tohold back arterial pressure and prevent blood from going back inside theventricle during diastole will be directly transferred to thestent/vessel wall interface. Therefore, the amount of radial forcerequired to keep the self-expanding stent/valve in contact with thevessel wall and not sliding will be much higher than in stents that donot have valves inside of them. Moreover, a self-expanding stent withoutsufficient radial force will end up dilating and contracting with eachheartbeat, thereby distorting the valve, affecting its function andpossibly migrating and dislodging completely. Simply increasing strutthickness of the self-expanding stent is not a practical solution as itruns the risk of larger profile and/or plastic deformation of theself-expanding stent.

In view of drawbacks associated with previously known techniques forendovascularly replacing a heart valve, it would be desirable to providemethods and apparatus that overcome those drawbacks.

SUMMARY OF THE INVENTION

One aspect of the present invention provides apparatus forendovascularly replacing a patient's heart valve, the apparatusincluding: a replacement valve; and an expandable anchor, wherein thereplacement valve and expandable anchor are configured for endovasculardelivery to the vicinity of the heart valve, and wherein at least aportion of the replacement valve is configured to evert about the anchorduring endovascular deployment.

Another aspect of the invention provides a method for endovascularlyreplacing a patient's heart valve. In some embodiments the methodincludes the steps of: endovascularly delivering a replacement valve andan expandable anchor to a vicinity of the heart valve; everting at leasta portion of the replacement valve about the anchor; and expanding theanchor to a deployed configuration.

Yet another aspect of the invention provides apparatus forendovascularly replacing a patient's heart valve including: an anchorcomprising a lip region and a skirt region; and a replacement valve,wherein at least a portion of the replacement valve is configured toevert about the anchor during endovascular deployment, and wherein thelip region and skirt region are configured for percutaneous expansion toengage the patient's heart valve.

Still another aspect of the present invention provides a method forendovascularly replacing a patient's heart valve, the method including:endovascularly delivering a replacement valve and an expandable anchorto a vicinity of the heart valve, endovascularly wrapping at least aportion of the replacement valve about the anchor, and expanding theanchor to a deployed configuration.

Another aspect of the present invention provides apparatus forendovascularly replacing a patient's heart valve, the apparatusincluding: a replacement valve, and an expandable anchor, wherein thereplacement valve and the anchor are configured for endovasculardelivery to a vicinity of the patient's heart valve, and wherein atleast a portion of the replacement valve is wrapped about an end of theanchor in a deployed configuration.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-B are elevational views of a replacement heart valve and anchoraccording to one embodiment of the invention.

FIGS. 2A-B are sectional views of the anchor and valve of FIG. 1.

FIGS. 3A-B show delivery and deployment of a replacement heart valve andanchor, such as the anchor and valve of FIGS. 1 and 2.

FIGS. 4A-F also show delivery and deployment of a replacement heartvalve and anchor, such as the anchor and valve of FIGS. 1 and 2.

FIGS. 5A-F show the use of a replacement heart valve and anchor toreplace an aortic valve.

FIGS. 6A-F show the use of a replacement heart valve and anchor with apositive registration feature to replace an aortic valve.

FIG. 7 shows the use of a replacement heart valve and anchor with analternative positive registration feature to replace an aortic valve.

FIGS. 8A-C show another embodiment of a replacement heart valve andanchor according to the invention.

FIGS. 9A-H show delivery and deployment of the replacement heart valveand anchor of FIG. 8.

FIG. 10 is a cross-sectional drawing of the delivery system used withthe method and apparatus of FIGS. 8 and 9.

FIGS. 11A-C show alternative locks for use with replacement heart valvesand anchors of this invention.

FIGS. 12A-C show a vessel wall engaging lock for use with replacementheart valves and anchors of this invention.

FIG. 13 demonstrates paravalvular leaking around a replacement heartvalve and anchor.

FIG. 14 shows a seal for use with a replacement heart valve and anchorof this invention.

FIGS. 15A-E show alternative arrangements of seals on a replacementheart valve and anchor.

FIGS. 16A-C show alternative seal designs for use with replacement heartvalves and anchors.

FIG. 17 show an alternative anchor lock embodiment in an unlockedconfiguration.

FIGS. 18A-B show the anchor lock of FIG. 17 in a locked configuration.

FIG. 19 shows an alternative anchor deployment tool attachment andrelease mechanism for use with the invention.

FIG. 20 shows the attachment and release mechanism of FIG. 19 in theprocess of being released.

FIG. 21 shows the attachment and release mechanism of FIGS. 19 and 20 ina released condition.

FIG. 22 shows an alternative embodiment of a replacement heart valve andanchor and a deployment tool according to the invention in an undeployedconfiguration.

FIG. 23 shows the replacement heart valve and anchor of FIG. 22 in apartially deployed configuration.

FIG. 24 shows the replacement heart valve and anchor of FIGS. 22 and 23in a more fully deployed configuration but with the deployment toolstill attached.

FIG. 25 shows yet another embodiment of the delivery and deploymentapparatus of the invention in use with a replacement heart valve andanchor.

FIG. 26 shows the delivery and deployment apparatus of FIG. 25 in theprocess of deploying a replacement heart valve and anchor.

FIG. 27 shows an embodiment of the invention employing seals at theinterface of the replacement heart valve and anchor and the patient'stissue.

FIG. 28 is a longitudinal cross-sectional view of the seal shown in FIG.27 in compressed form.

FIG. 29 is a transverse cross-sectional view of the seal shown in FIG.28.

FIG. 30 is a longitudinal cross-sectional view of the seal shown in FIG.27 in expanded form.

FIG. 31 is a transverse cross-sectional view of the seal shown in FIG.30.

FIG. 32 shows yet another embodiment of the replacement heart valve andanchor of this invention in an undeployed configuration.

FIG. 33 shows the replacement heart valve and anchor of FIG. 32 in adeployed configuration.

FIG. 34 shows the replacement heart valve and anchor of FIGS. 32 and 33deployed in a patient's heart valve.

FIGS. 35A-H show yet another embodiment of a replacement heart valve,anchor and deployment system according to this invention.

FIGS. 36A-E show more detail of the anchor of the embodiment shown inFIGS. 35A-H.

FIGS. 37A-B show other embodiments of the replacement heart valve andanchor of the invention.

FIGS. 38A-C illustrate a method for endovascularly replacing a patient'sdiseased heart valve.

FIGS. 39A-G are side views, partially in section, as well as anisometric view, illustrating a method for endovascularly replacing apatient's diseased heart valve with an embodiment of the presentinvention comprising a replacement valve that is not connected to theexpandable anchor, the replacement valve wrapped about the anchor,illustratively by everting during deployment.

FIGS. 40A-D are side views, partially in section, illustrating a methodfor endovascularly replacing a patient's diseased heart valve withanother everting embodiment of the present invention.

FIGS. 41A-E are side views, partially in section, illustrating a methodfor endovascularly replacing a patient's diseased heart valve with yetanother everting embodiment of the present invention, wherein thereplacement valve and the anchor are telescoped relative to one anotherduring endovascular delivery.

FIGS. 42A-B are side-sectional views of alternative everting apparatuscomprising everting valve leaflets.

FIGS. 43A-B, are side-sectional views of further alternative evertingapparatus comprising a locking mechanism coupled to the evertingsegment.

FIGS. 44A-B are side-sectional views of telescoping embodiments of thepresent invention comprising U-shaped valve frames.

DETAILED DESCRIPTION OF THE INVENTION

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. For example, for thetwo-part locking mechanisms described hereinafter, it will be apparentthat the locations of the male and female elements may be reversed. Itis intended that the following claims define the scope of the inventionand that methods and structures within the scope of these claims andtheir equivalents be covered thereby.

With reference now to FIGS. 1-4, a first embodiment of replacement heartvalve apparatus in accordance with the present invention is described,including a method of actively foreshortening and expanding theapparatus from a delivery configuration and to a deployed configuration.Apparatus 10 comprises replacement valve 20 disposed within and coupledto anchor 30. FIG. 1 schematically illustrate individual cells of anchor30 of apparatus 10, and should be viewed as if the cylindrical anchorhas been cut open and laid flat. FIG. 2 schematically illustrate adetail portion of apparatus 10 in side-section.

Anchor 30 has a lip region 32, a skirt region 34 and a body region 36.First, second and third posts 38 a, 38 b and 38 c, respectively, arecoupled to skirt region 34 and extend within lumen 31 of anchor 30.Posts 38 preferably are spaced 120° apart from one another about thecircumference of anchor 30.

Anchor 30 preferably is fabricated by using self-expanding patterns(laser cut or chemically milled), braids and materials, such as astainless steel, nickel-titanium (“Nitinol”) or cobalt chromium, butalternatively may be fabricated using balloon-expandable patterns wherethe anchor is designed to plastically deform to its final shape by meansof balloon expansion. Replacement valve 20 is preferably made frombiologic tissues, e.g. porcine valve leaflets or bovine or equinepericardium tissues or human cadaver tissue. Alternatively, it can bemade from tissue engineered materials (such as extracellular matrixmaterial from Small Intestinal Submucosa (SIS)) or may be prosthetic andmade from an elastomeric polymer or silicone, Nitinol or stainless steelmesh or pattern (sputtered, chemically milled or laser cut). The leafletmay also be made of a composite of the elastomeric or silicone materialsand metal alloys or other fibers such Kevlar or carbon. Annular base 22of replacement valve 20 preferably is coupled to skirt region 34 ofanchor 30, while commissures 24 of replacement valve leaflets 26 arecoupled to and supported by posts 38.

Anchor 30 may be actuated using external non-hydraulic or non-pneumaticforce to actively foreshorten in order to increase its radial strength.As shown below, the proximal and distal end regions of anchor 30 may beactuated independently. The anchor and valve may be placed and expandedin order to visualize their location with respect to the native valveand other anatomical features and to visualize operation of the valve.The anchor and valve may thereafter be repositioned and even retrievedinto the delivery sheath or catheter. The apparatus may be delivered tothe vicinity of the patient's aortic valve in a retrograde approach in acatheter having a diameter no more than 23 french, preferably no morethan 21 french, more preferably no more than 19 french, or morepreferably no more than 17 french. Upon deployment the anchor andreplacement valve capture the native valve leaflets and positively lockto maintain configuration and position.

A deployment tool is used to actuate, reposition, lock and/or retrieveanchor 30. In order to avoid delivery of anchor 30 on a balloon forballoon expansion, a non-hydraulic or non-pneumatic anchor actuator isused. In this embodiment, the actuator is a deployment tool thatincludes distal region control wires 50, control rods or tubes 60 andproximal region control wires 62. Locks 40 include posts or arms 38preferably with male interlocking elements 44 extending from skirtregion 34 and mating female interlocking elements 42 in lip region 32.Male interlocking elements 44 have eyelets 45. Control wires 50 passfrom a delivery system for apparatus 10 through female interlockingelements 42, through eyelets 45 of male interlocking elements 44, andback through female interlocking elements 42, such that a double strandof wire 50 passes through each female interlocking element 42 formanipulation by a medical practitioner external to the patient toactuate and control the anchor by changing the anchor's shape. Controlwires 50 may comprise, for example, strands of suture.

Tubes 60 are reversibly coupled to apparatus 10 and may be used inconjunction with wires 50 to actuate anchor 30, e.g., to foreshorten andlock apparatus 10 in the fully deployed configuration. Tubes 60 alsofacilitate repositioning and retrieval of apparatus 10, as describedhereinafter. For example, anchor 30 may be foreshortened and radiallyexpanded by applying a distally directed force on tubes 60 whileproximally retracting wires 50. As seen in FIG. 3, control wires 62 passthrough interior lumens 61 of tubes 60. This ensures that tubes 60 arealigned properly with apparatus 10 during deployment and foreshortening.Control wires 62 can also actuate anchor 60; proximally directed forceson control wires 62 contacts the proximal lip region 32 of anchor 30.Wires 62 also act to couple and decouple tubes 60 from apparatus 10.Wires 62 may comprise, for example, strands of suture.

FIGS. 1A and 2A illustrate anchor 30 in a delivery configuration or in apartially deployed configuration (e.g., after dynamic self-expansionfrom a constrained delivery configuration within a delivery sheath).Anchor 30 has a relatively long length and a relatively small width inthe delivery or partially deployed configuration, as compared to theforeshortened and fully deployed configuration of FIGS. 1B and 2B.

In FIGS. 1A and 2A, replacement valve 20 is collapsed within lumen 31 ofanchor 30. Retraction of wires 50 relative to tubes 60 foreshortensanchor 30, which increases the anchor's width while decreasing itslength. Such foreshortening also properly seats replacement valve 20within lumen 31 of anchor 30. Imposed foreshortening will enhance radialforce applied by apparatus 10 to surrounding tissue over at least aportion of anchor 30. In some embodiments, the anchor is capable ofexerting an outward radial force on surrounding tissue to engage thetissue in such way to prevent migration of anchor. This outward radialforce is preferably greater than 2 psi, more preferably greater than 4psi, more preferably greater than 6 psi, more preferably greater than 8psi, more preferably greater than 10 psi, more preferably greater than20 psi, or more preferably greater than 30 psi. Enhanced radial force ofthe anchor is also important for enhanced crush resistance of the anchoragainst the surrounding tissue due to the healing response (fibrosis andcontraction of annulus over a longer period of time) or to dynamicchanges of pressure and flow at each heart beat. In an alternativeembodiment, the anchor pattern or braid is designed to have gaps orareas where the native tissue is allowed to protrude through the anchorslightly (not shown) and, as the foreshortening is applied, the tissueand anchor become intertwined and immobilized. This feature wouldprovide additional means to prevent anchor migration and enhancelong-term stability of the device.

Deployment of apparatus 10 is fully reversible until lock 40 has beenlocked via mating of male interlocking elements 44 with femaleinterlocking elements 42. Deployment is then completed by decouplingtubes 60 from lip section 32 of anchor 30 by retracting one end of eachwire 62 relative to the other end of the wire, and by retracting one endof each wire 50 relative to the other end of the wire until each wirehas been removed from eyelet 45 of its corresponding male interlockingelement 44.

As best seen in FIG. 2B, body region 36 of anchor 30 optionally maycomprise barb elements 37 that protrude from anchor 30 in the fullydeployed configuration, for example, for engagement of a patient'snative valve leaflets and to preclude migration of the apparatus.

With reference now to FIG. 3, a delivery and deployment system for aself-expanding embodiment of apparatus 10 including a sheath 110 havinga lumen 112. Self-expanding anchor 30 is collapsible to a deliveryconfiguration within lumen 112 of sheath 110, such that apparatus 10 maybe delivered via delivery system 100. As seen in FIG. 3A, apparatus 10may be deployed from lumen 112 by retracting sheath 110 relative toapparatus 10, control wires 50 and tubes 60, which causes anchor 30 todynamically self-expand to a partially deployed configuration. Controlwires 50 then are retracted relative to apparatus 10 and tubes 60 toimpose foreshortening upon anchor 30, as seen in FIG. 3B.

During foreshortening, tubes 60 push against lip region 32 of anchor 30,while wires 50 pull on posts 38 of the anchor. Wires 62 may be retractedalong with wires 50 to enhance the distally directed pushing forceapplied by tubes 60 to lip region 32. Continued retraction of wires 50relative to tubes 60 would lock locks 40 and fully deploy apparatus 10with replacement valve 20 properly seated within anchor 30, as in FIGS.1B and 2B. Apparatus 10 comprises enhanced radial strength in the fullydeployed configuration as compared to the partially deployedconfiguration of FIG. 3A. Once apparatus 10 has been fully deployed,wires 50 and 62 may be removed from apparatus 10, thereby separatingdelivery system 100 and tubes 60 from the apparatus.

Deployment of apparatus 10 is fully reversible until locks 40 have beenactuated. For example, just prior to locking the position of the anchorand valve and the operation of the valve may be observed underfluoroscopy. If the position needs to be changed, by alternatelyrelaxing and reapplying the proximally directed forces exerted bycontrol wires 50 and/or control wires 62 and the distally directedforces exerted by tubes 60, expansion and contraction of the lip andskirt regions of anchor 30 may be independently controlled so that theanchor and valve can be moved to, e.g., avoid blocking the coronaryostia or impinging on the mitral valve. Apparatus 10 may also becompletely retrieved within lumen 112 of sheath 110 by simultaneouslyproximally retracting wires 50 and tubes 60/wires 62 relative to sheath110. Apparatus 10 then may be removed from the patient or repositionedfor subsequent redeployment.

Referring now to FIG. 4, step-by-step deployment of apparatus 10 viadelivery system 100 is described. In FIG. 4A, sheath 110 is retractedrelative to apparatus 10, wires 50 and tubes 60, thereby causingself-expandable anchor 30 to dynamically self-expand apparatus 10 fromthe collapsed delivery configuration within lumen 112 of sheath 110 tothe partially deployed configuration. Apparatus 10 may then bedynamically repositioned via tubes 60 to properly orient the apparatus,e.g. relative to a patient's native valve leaflets.

In FIG. 4B, control wires 50 are retracted while tubes 60 are advanced,thereby urging lip region 32 of anchor 30 in a distal direction whileurging posts 38 of the anchor in a proximal direction. This foreshortensapparatus 10, as seen in FIG. 4C. Deployment of apparatus 10 is fullyreversible even after foreshortening has been initiated and has advancedto the point illustrated in FIG. 4C.

In FIG. 4D, continued foreshortening causes male interlocking elements44 of locks 40 to engage female interlocking elements 42. The maleelements mate with the female elements, thereby locking apparatus 10 inthe foreshortened configuration, as seen in FIG. 4E. Wires 50 are thenpulled through eyelets 45 of male elements 44 to remove the wires fromapparatus 10, and wires 62 are pulled through the proximal end of anchor30 to uncouple tubes 60 from the apparatus, thereby separating deliverysystem 100 from apparatus 10. Fully deployed apparatus 10 is shown inFIG. 4F.

Referring to FIG. 5, a method of endovascularly replacing a patient'sdiseased aortic valve with apparatus 10 and delivery system 100 isdescribed. As seen in FIG. 5A, sheath 110 of delivery system 100, havingapparatus 10 disposed therein, is endovascularly advanced over guidewire G, preferably in a retrograde fashion (although an antegrade orhybrid approach alternatively may be used), through a patient's aorta Ato the patient's diseased aortic valve AV. A nosecone 102 precedessheath 110 in a known manner. In FIG. 5B, sheath 110 is positioned suchthat its distal region is disposed within left ventricle LV of thepatient's heart H.

Apparatus 10 is deployed from lumen 112 of sheath 110, for example,under fluoroscopic guidance, such that anchor 30 of apparatus 10dynamically self-expands to a partially deployed configuration, as inFIG. 5C. Advantageously, apparatus 10 may be retracted within lumen 112of sheath 110 via wires 50—even after anchor 30 has dynamically expandedto the partially deployed configuration, for example, to abort theprocedure or to reposition apparatus 10 or delivery system 100. As yetanother advantage, apparatus 10 may be dynamically repositioned, e.g.via sheath 110 and/or tubes 60, in order to properly align the apparatusrelative to anatomical landmarks, such as the patient's coronary ostiaor the patient's native valve leaflets L. When properly aligned, skirtregion 34 of anchor 30 preferably is disposed distal of the leaflets,while body region 36 is disposed across the leaflets and lip region 32is disposed proximal of the leaflets.

Once properly aligned, wires 50 are retracted relative to tubes 60 toimpose foreshortening upon anchor 30 and expand apparatus 10 to thefully deployed configuration, as in FIG. 5D. Foreshortening increasesthe radial strength of anchor 30 to ensure prolonged patency of valveannulus An, as well as to provide a better seal for apparatus 10 thatreduces paravalvular regurgitation. As seen in FIG. 5E, locks 40maintain imposed foreshortening. Replacement valve 20 is properly seatedwithin anchor 30, and normal blood flow between left ventricle LV andaorta A is thereafter regulated by apparatus 10. Deployment of apparatus10 advantageously is fully reversible until locks 40 have been actuated.

As seen in FIG. 5F, wires 50 are pulled from eyelets 45 of male elements44 of locks 40, tubes 60 are decoupled from anchor 30, e.g. via wires62, and delivery system 100 is removed from the patient, therebycompleting deployment of apparatus 10. Optional barb elements 37 engagethe patient's native valve leaflets, e.g. to preclude migration of theapparatus and/or reduce paravalvular regurgitation.

With reference now to FIG. 6, a method of endovascularly replacing apatient's diseased aortic valve with apparatus 10 is provided, whereinproper positioning of the apparatus is ensured via positive registrationof a modified delivery system to the patient's native valve leaflets. InFIG. 6A, modified delivery system 100′ delivers apparatus 10 to diseasedaortic valve AV within sheath 110. As seen in FIGS. 6B and 6C, apparatus10 is deployed from lumen 112 of sheath 110, for example, underfluoroscopic guidance, such that anchor 30 of apparatus 10 dynamicallyself-expands to a partially deployed configuration. As when deployed viadelivery system 100, deployment of apparatus 10 via delivery system 100′is fully reversible until locks 40 have been actuated.

Delivery system 100′ comprises leaflet engagement element 120, whichpreferably self-expands along with anchor 30. Engagement element 120 isdisposed between tubes 60 of delivery system 100′ and lip region 32 ofanchor 30. Element 120 releasably engages the anchor. As seen in FIG.6C, the element is initially deployed proximal of the patient's nativevalve leaflets L. Apparatus 10 and element 120 then may beadvanced/dynamically repositioned until the engagement elementpositively registers against the leaflets, thereby ensuring properpositioning of apparatus 10. Also, delivery system 100′ includes filterstructure 61A (e.g., filter membrane or braid) as part of push tubes 60to act as an embolic protection element. Emboli can be generated duringmanipulation and placement of anchor, from either diseased nativeleaflet or surrounding aortic tissue, and can cause blockage. Arrows 61Bin FIG. 6E show blood flow through filter structure 61A where blood isallowed to flow but emboli is trapped in the delivery system and removedwith it at the end of the procedure.

Alternatively, foreshortening may be imposed upon anchor 30 whileelement 120 is disposed proximal of the leaflets, as in FIG. 6D. Uponpositive registration of element 120 against leaflets L, element 120precludes further distal migration of apparatus 10 during additionalforeshortening, thereby reducing a risk of improperly positioning theapparatus. FIG. 6E details engagement of element 120 against the nativeleaflets. As seen in FIG. 6F, once apparatus 10 is fully deployed,element 120, wires 50 and tubes 60 are decoupled from the apparatus, anddelivery system 100′ is removed from the patient, thereby completing theprocedure.

With reference to FIG. 7, an alternative embodiment of the apparatus ofFIG. 6 is described, wherein leaflet engagement element 120 is coupledto anchor 30 of apparatus 10′, rather than to delivery system 100.Engagement element 120 remains implanted in the patient post-deploymentof apparatus 10′. Leaflets L are sandwiched between lip region 32 ofanchor 30 and element 120 in the fully deployed configuration. In thismanner, element 120 positively registers apparatus 10′ relative to theleaflets and precludes distal migration of the apparatus over time.

Referring now to FIG. 8, an alternative delivery system adapted for usewith a balloon expandable embodiment of the present invention isdescribed. In FIG. 8A, apparatus 10″ comprises anchor 30′ that may befabricated from balloon-expandable materials. Delivery system 100″comprises inflatable member 130 disposed in a deflated configurationwithin lumen 31 of anchor 30′. In FIG. 8B, optional outer sheath 110 isretracted, and inflatable member 130 is inflated to expand anchor 30′ tothe fully deployed configuration. As inflatable member 130 is beingdeflated, as in earlier embodiments, wires 50 and 62 and tubes 60 may beused to assist deployment of anchor 30′ and actuation of locks 40, aswell as to provide reversibility and retrievability of apparatus 10″prior to actuation of locks 40. Next, wires 50 and 62 and tubes 60 areremoved from apparatus 10″, and delivery system 100″ is removed, as seenin FIG. 8C.

As an alternative delivery method, anchor 30′ may be partially deployedvia partial expansion of inflatable member 130. The inflatable memberwould then be advanced within replacement valve 20 prior to inflation ofinflatable member 130 and full deployment of apparatus 10″. Inflationpressures used will range from about 3 to 6 atm, or more preferably fromabout 4 to 5 atm, though higher and lower atm pressures may also be used(e.g., greater than 3 atm, more preferably greater than 4 atm, morepreferably greater than 5 atm, or more preferably greater than 6 atm).Advantageously, separation of inflatable member 130 from replacementvalve 20, until partial deployment of apparatus 10″ at a treatment site,is expected to reduce a delivery profile of the apparatus, as comparedto previously known apparatus. This profile reduction may facilitateretrograde delivery and deployment of apparatus 10″, even when anchor30′ is balloon-expandable.

Although anchor 30′ has illustratively been described as fabricated fromballoon-expandable materials, it should be understood that anchor 30′alternatively may be fabricated from self-expanding materials whoseexpansion optionally may be balloon-assisted. In such a configuration,anchor 30′ would expand to a partially deployed configuration uponremoval of outer sheath 110. If required, inflatable member 130 thenwould be advanced within replacement valve 20 prior to inflation.Inflatable member 130 would assist full deployment of apparatus 10″, forexample, when the radial force required to overcome resistance fromimpinging tissue were too great to be overcome simply by manipulation ofwires 50 and tubes 60. Advantageously, optional placement of inflatablemember 130 within replacement valve 20, only after dynamicself-expansion of apparatus 10″ to the partially deployed configurationat a treatment site, is expected to reduce a delivery profile of theapparatus, as compared to previously known apparatus. This reduction mayfacilitate retrograde delivery and deployment of apparatus 10″.

With reference to FIGS. 9 and 10, methods and apparatus for aballoon-assisted embodiment of the present invention are described ingreater detail. FIGS. 9 and 10 illustratively show apparatus 10′ of FIG.7 used in combination with delivery system 100″ of FIG. 8. FIG. 10illustrates a sectional view of delivery system 100″. Inner shaft 132 ofinflatable member 130 preferably is about 4 Fr in diameter, andcomprises lumen 133 configured for passage of guidewire G, having adiameter of about 0.035″, therethrough. Push tubes 60 and pull wires 50pass through guidetube 140, which preferably has a diameter of about 15Fr or smaller. Guide tube 140 is disposed within lumen 112 of outersheath 110, which preferably has a diameter of about 17 Fr or smaller.

In FIG. 9A, apparatus 10′ is delivered to diseased aortic valve AVwithin lumen 112 of sheath 110. In FIG. 9B, sheath 110 is retractedrelative to apparatus 10′ to dynamically self-expand the apparatus tothe partially deployed configuration. Also retracted and removed isnosecone 102, which is attached to a pre-slit lumen (not shown) thatfacilitates its removal prior to loading and advancing of a regularangioplasty balloon catheter over guidewire and inside delivery system110.

In FIG. 9C, pull wires 50 and push tubes 60 are manipulated fromexternal to the patient to foreshorten anchor 30 and sufficiently expandlumen 31 of the anchor to facilitate advancement of inflatable member130 within replacement valve 20. Also shown is the tip of an angioplastycatheter 130 being advanced through delivery system 110.

The angioplasty balloon catheter or inflatable member 130 then isadvanced within the replacement valve, as in FIG. 9D, and additionalforeshortening is imposed upon anchor 30 to actuate locks 40, as in FIG.9E. The inflatable member is inflated to further displace the patient'snative valve leaflets L and ensure adequate blood flow through, andlong-term patency of, replacement valve 20, as in FIG. 9F. Inflatablemember 130 then is deflated and removed from the patient, as in FIG. 9G.A different size angioplasty balloon catheter could be used repeat thesame step if deemed necessary by the user. Push tubes 60 optionally maybe used to further set leaflet engagement element 120, or optional barbsB along posts 38, more deeply within leaflets L, as in FIG. 9H. Then,delivery system 100″ is removed from the patient, thereby completingpercutaneous heart valve replacement.

As will be apparent to those of skill in the art, the order of imposedforeshortening and balloon expansion described in FIGS. 9 and 10 is onlyprovided for the sake of illustration. The actual order may varyaccording to the needs of a given patient and/or the preferences of agiven medical practitioner. Furthermore, balloon-assist may not berequired in all instances, and the inflatable member may act merely as asafety precaution employed selectively in challenging clinical cases.

Referring now to FIG. 11, alternative locks for use with apparatus ofthe present invention are described. In FIG. 11A, lock 40′ comprisesmale interlocking element 44 as described previously. However, femaleinterlocking element 42′ illustratively comprises a triangular shape, ascompared to the round shape of interlocking element 42 describedpreviously. The triangular shape of female interlocking element 42′ mayfacilitate mating of male interlocking element 44 with the femaleinterlocking element without necessitating deformation of the maleinterlocking element.

In FIG. 11B, lock 40″ comprises alternative male interlocking element44′ having multiple in-line arrowheads 46 along posts 38. Each arrowheadcomprises resiliently deformable appendages 48 to facilitate passagethrough female interlocking element 42. Appendages 48 optionallycomprise eyelets 49, such that control wire 50 or a secondary wire maypass therethrough to constrain the appendages in the deformedconfiguration. To actuate lock 40″, one or more arrowheads 46 of maleinterlocking element 44′ are drawn through female interlocking element42, and the wire is removed from eyelets 49, thereby causing appendages48 to resiliently expand and actuate lock 40″.

Advantageously, providing multiple arrowheads 46 along posts 38 yields aratchet that facilitates in-vivo determination of a degree offoreshortening imposed upon apparatus of the present invention.Furthermore, optionally constraining appendages 48 of arrowheads 46 viaeyelets 49 prevents actuation of lock 40″ (and thus deployment ofapparatus of the present invention) even after male element 44′ has beenadvanced through female element 42. Only after a medical practitionerhas removed the wire constraining appendages 48 is lock 40″ fullyengaged and deployment no longer reversible.

Lock 40′″ of FIG. 11C is similar to lock 40″ of FIG. 11B, except thatoptional eyelets 49 on appendages 48 have been replaced by optionalovertube 47. Overtube 47 serves a similar function to eyelets 49 byconstraining appendages 48 to prevent locking until a medicalpractitioner has determined that apparatus of the present invention hasbeen foreshortened and positioned adequately at a treatment site.Overtube 47 is then removed, which causes the appendages to resilientlyexpand, thereby fully actuating lock 40′″.

With reference to FIG. 12, an alternative locking mechanism is describedthat is configured to engage the patient's aorta. Male interlockingelements 44″ of locks 40″″ comprise arrowheads 46′ having sharpenedappendages 48′. Upon expansion from the delivery configuration of FIG.12A to the foreshortened configuration of FIG. 12B, apparatus 10positions sharpened appendages 48′ adjacent the patient's aorta A.Appendages 48′ engage the aortic wall and reduce a risk of devicemigration over time.

With reference now to FIG. 13, a risk of paravalvular leakage orregurgitation around apparatus of the present invention is described. InFIG. 13, apparatus 10 has been implanted at the site of diseased aorticvalve AV, for example, using techniques described hereinabove. Thesurface of native valve leaflets L is irregular, and interface I betweenleaflets L and anchor 30 may comprise gaps where blood B may seepthrough. Such leakage poses a risk of blood clot formation orinsufficient blood flow.

Referring to FIG. 14, optional elements for reducing regurgitation orleakage are described. Compliant sacs 200 may be disposed about theexterior of anchor 30 to provide a more efficient seal along irregularinterface I. Sacs 200 may be filled with an appropriate material, forexample, water, blood, foam or a hydrogel. Alternative fill materialswill be apparent.

With reference to FIG. 15, illustrative arrangements for sacs 200 areprovided. In FIG. 15A, sacs 200 are provided as discrete sacs atdifferent positions along the height of anchor 30. In FIG. 15B, the sacsare provided as continuous cylinders at various heights. In FIG. 15C, asingle sac is provided with a cylindrical shape that spans multipleheights. The sacs of FIG. 15D are discrete, smaller and provided inlarger quantities. FIG. 15E provides a spiral sac. Alternative sacconfigurations will be apparent to those of skill in the art.

With reference to FIG. 16, exemplary techniques for fabricating sacs 200are provided. In FIG. 16A, sacs 200 comprise ‘fish-scale’ slots 202 thatmay be back-filled, for example, with ambient blood passing throughreplacement valve 20. In FIG. 16B, the sacs comprise pores 204 that maybe used to fill the sacs. In FIG. 16C, the sacs open to lumen 31 ofanchor 30 and are filled by blood washing past the sacs as the bloodmoves through apparatus 10.

FIGS. 17 and 18 show yet another alternative embodiment of the anchorlock. Anchor 300 has a plurality of male interlocking elements 302having eyelets 304 formed therein. Male interlocking elements areconnected to braided structure 300 by inter-weaving elements 302 (and308) or alternatively suturing, soldering, welding, or connecting withadhesive. Valve commissures 24 are connected to male interlockingelements 302 along their length. Replacement valve 20 annular base 22 isconnected to the distal end 34 of anchor 300 (or 30) as is illustratedin FIGS. 1A and 1B. Male interlocking elements 302 also include holes306 that mate with tabs 310 extending into holes 312 in femaleinterlocking elements 308. To lock, control wires 314 passing througheyelets 304 and holes 312 are pulled proximally with respect to theproximal end of braided anchor 300 to draw the male interlockingelements through holes 312 so that tabs 310 engage holes 306 in maleinterlocking elements 302. Also shown is release wires 314B that passthrough eyelet 304B in female interlocking element 308. If needed,during the procedure, the user may pull on release wires 314B, therebyreversing orientation of tabs 310, releasing the anchor and allowing forrepositioning of the device or its removal from the patient. Only whenfinally positioned as desired by the operating physician, would releasewire 314B and control wire 314 be cut and removed from the patient withthe delivery system.

FIGS. 19-21 show an alternative way of releasing the connection betweenthe anchor and its actuating tubes and control wires. Control wires 62extend through tubes 60 from outside the patient, loop through theproximal region of anchor 30 and extend partially back into tube 60. Thedoubled up portion of control wire 62 creates a force fit within tube 60that maintains the control wire's position with respect to tube 60 whenall control wires 62 are pulled proximally to place a proximallydirected force on anchor 30. When a single control wire 62 is pulledproximally, however, the frictional fit between that control wire andthe tube in which it is disposed is overcome, enabling the end 63 ofcontrol wire 62 to pull free of the tube, as shown in FIG. 21, therebyreleasing anchor 30.

FIGS. 22-24 show an alternative embodiment of the anchor. Anchor 350 ismade of a metal braid, such as Nitinol or stainless steel. A replacementvalve 354 is disposed within anchor 350 and supported by a replacementvalve support, such as the posts described in earlier embodiments.Anchor 350 preferably is fabricated from a single strand of metal wirewound into the braid. It is expected that fabricating anchor 350 from asingle strand of wire will facilitate deployment of the anchor, as wellas retrieval of the anchor, by more evenly distributing forces appliedto the anchor. Fabrication from a single strand is also expected tofacilitate coupling of replacement valve 354 to the anchor, as well ascoupling and decoupling of control wires (not shown) and tubes 352thereto. Anchor 350 is actuated in substantially the same way as anchor30 of FIGS. 1-4 through the application of proximally and distallydirected forces from control wires and tubes 352 and may be locked inits expanded deployed configuration, as described above. The employedconfiguration of anchor 354 may have the shape and anchoringcharacteristics described with respect to other embodiments as well.

The braid forming anchor 350 (as well as that forming previouslydescribed anchor 30) optionally may be locally increased in diameter,e.g. via dipping in silicone or a hydrogel, in order to provide a betteror complete seal against the patient's anatomy. An improved seal isexpected to reduce paravalvular leakage, as well as migration of theanchor over time. The local increase in diameter of the braid may, forexample, be provided over a full radial segment of anchor 350.

FIGS. 25 and 26 show yet another embodiment of the delivery anddeployment apparatus of the invention. As an alternative to the balloonexpansion method described with respect to FIG. 8, in this embodimentthe nosecone (e.g., element 102 of FIG. 5) is replaced by an angioplastyballoon catheter 360. Thus, angioplasty balloon catheter 360 precedessheath 110 on guidewire G. When anchor 30 and valve 20 are expandedthrough the operation of tubes 60 and the control wires (not shown) asdescribed above, balloon catheter 360 is retracted proximally within theexpanded anchor and valve and expanded further as described above withrespect to FIG. 8.

As an alternative, or in addition, to further expansion of ballooncatheter 360 within valve 20 and expanded anchor 30 to further expandthe anchor, the balloon may be deflated prior to proximal retractionwithin and past the valve and anchor. In this manner, balloon catheter360 may act as an atraumatic nosecone during delivery of valve 20 andanchor 30, but then may be deflated to provide a reduced profile, ascompared to a standard nosecone, during retrieval of the ballooncatheter through the deployed valve. It is expected that a smallerballoon catheter 360 may be provided when the catheter is utilizedmerely in place of a nosecone than when the catheter is also utilized tocomplete expansion of anchor 30.

FIGS. 27-31 show seals 370 that expand over time to seal the interfacebetween the anchor and valve and the patient's tissue. Seals 370 arepreferably formed from Nitinol wire surrounded by an expandable foam. Asshown in cross-section in FIGS. 28 and 29, at the time of deployment,the foam 372 is compressed about the wire 374 and held in the compressedform by a time-released coating 376. After deployment, coating 376dissolves in vivo to allow foam 372 to expand, as shown in FIGS. 30 and31.

FIGS. 32-34 show another way to seal the replacement valve againstleakage. A fabric seal 380 extends from the distal end of valve 20 andback proximally over anchor 30 during delivery. When deployed, as shownin FIGS. 33 and 34, fabric seal 380 bunches up to create fabric flapsand pockets that extend into spaces formed by the native valve leaflets382, particularly when the pockets are filled with blood in response tobackflow blood pressure. This arrangement creates a seal around thereplacement valve.

FIGS. 35A-H show another embodiment of a replacement heart valveapparatus in accordance with the present invention. Apparatus 450comprises replacement valve 460 (see FIGS. 37B and 38C) disposed withinand coupled to anchor 470. Replacement valve 460 is preferably biologic,e.g. porcine, but alternatively may be synthetic. Anchor 470 preferablyis fabricated from self-expanding materials, such as a stainless steelwire mesh or a nickel-titanium alloy (“Nitinol”), and comprises lipregion 472, skirt region 474, and body regions 476 a, 476 b and 476 c.Replacement valve 460 preferably is coupled to skirt region 474, butalternatively may be coupled to other regions of the anchor. Asdescribed hereinbelow, lip region 472 and skirt region 474 areconfigured to expand and engage/capture a patient's native valveleaflets, thereby providing positive registration, reducing paravalvularregurgitation, reducing device migration, etc.

As seen in FIG. 35A, apparatus 450 is collapsible to a deliveryconfiguration, wherein the apparatus may be delivered via deliverysystem 410. Delivery system 410 comprises sheath 420 having lumen 422,as well as wires 424 a and 424 b seen in FIGS. 35D-35G. Wires 424 a areconfigured to expand skirt region 474 of anchor 470, as well asreplacement valve 460 coupled thereto, while wires 424 b are configuredto expand lip region 472.

As seen in FIG. 35B, apparatus 450 may be delivered and deployed fromlumen 422 of catheter 420 while the apparatus is disposed in thecollapsed delivery configuration. As seen in FIGS. 35B-35D, catheter 420is retracted relative to apparatus 450, which causes anchor 470 todynamically self-expand to a partially deployed configuration. Wires 424a are then retracted to expand skirt region 474, as seen in FIGS. 35Eand 35F. Preferably, such expansion may be maintained via lockingfeatures described hereinafter.

In FIG. 35G, wires 424 b are retracted to expand lip region 472 andfully deploy apparatus 450. As with skirt region 474, expansion of lipregion 472 preferably may be maintained via locking features. After bothlip region 472 and skirt region 474 have been expanded, wires 424 may beremoved from apparatus 450, thereby separating delivery system 410 fromthe apparatus. Delivery system 410 then may be removed, as seen in FIG.35H.

As will be apparent to those of skill in the art, lip region 472optionally may be expanded prior to expansion of skirt region 474. Asyet another alternative, lip region 472 and skirt region 474 optionallymay be expanded simultaneously, in parallel, in a step-wise fashion orsequentially. Advantageously, delivery of apparatus 450 is fullyreversible until lip region 472 or skirt region 474 has been locked inthe expanded configuration.

With reference now to FIGS. 36A-E, individual cells of anchor 470 ofapparatus 450 are described to detail deployment and expansion of theapparatus. In FIG. 36A, individual cells of lip region 472, skirt region474 and body regions 476 a, 476 b and 476 c are shown in the collapseddelivery configuration, as they would appear while disposed within lumen422 of sheath 420 of delivery system 410 of FIG. 35. A portion of thecells forming body regions 476, for example, every ‘nth’ row of cells,comprises locking features.

Body region 476 a comprises male interlocking element 482 of lip lock480, while body region 476 b comprises female interlocking element 484of lip lock 480. Male element 482 comprises eyelet 483. Wire 424 bpasses from female interlocking element 484 through eyelet 483 and backthrough female interlocking element 484, such that there is a doublestrand of wire 424 b that passes through lumen 422 of catheter 420 formanipulation by a medical practitioner external to the patient. Bodyregion 476 b further comprises male interlocking element 492 of skirtlock 490, while body region 476 c comprises female interlocking element494 of the skirt lock. Wire 424 a passes from female interlockingelement 494 through eyelet 493 of male interlocking element 492, andback through female interlocking element 494. Lip lock 480 is configuredto maintain expansion of lip region 472, while skirt lock 490 isconfigured to maintain expansion of skirt region 474.

In FIG. 36B, anchor 470 is shown in the partially deployedconfiguration, e.g., after deployment from lumen 422 of sheath 420. Bodyregions 476, as well as lip region 472 and skirt region 474, self-expandto the partially deployed configuration. Full deployment is thenachieved by retracting wires 424 relative to anchor 470, and expandinglip region 472 and skirt region 474 outward, as seen in FIGS. 36C and36D. As seen in FIG. 36E, expansion continues until the male elementsengage the female interlocking elements of lip lock 480 and skirt lock490, thereby maintaining such expansion (lip lock 480 shown in FIG.36E). Advantageously, deployment of apparatus 450 is fully reversibleuntil lip lock 480 and/or skirt lock 490 has been actuated.

With reference to FIGS. 37A-B, isometric views, partially in section,further illustrate apparatus 450 in the fully deployed and expandedconfiguration. FIG. 37A illustrates the wireframe structure of anchor470, while FIG. 37B illustrates an embodiment of anchor 470 covered in abiocompatible material B. Placement of replacement valve 460 withinapparatus 450 may be seen in FIG. 37B. The patient's native valve iscaptured between lip region 472 and skirt region 474 of anchor 470 inthe fully deployed configuration (see FIG. 38B).

Referring to FIGS. 38A-C, in conjunction with FIGS. 35 and 36, a methodfor endovascularly replacing a patient's diseased aortic valve withapparatus 450 is described. Delivery system 410, having apparatus 450disposed therein, is endovascularly advanced, preferably in a retrogradefashion, through a patient's aorta A to the patient's diseased aorticvalve AV. Sheath 420 is positioned such that its distal end is disposedwithin left ventricle LV of the patient's heart H. As described withrespect to FIG. 35, apparatus 450 is deployed from lumen 422 of sheath420, for example, under fluoroscopic guidance, such that skirt section474 is disposed within left ventricle LV, body section 476 b is disposedacross the patient's native valve leaflets L, and lip section 472 isdisposed within the patient's aorta A. Advantageously, apparatus 450 maybe dynamically repositioned to obtain proper alignment with theanatomical landmarks. Furthermore, apparatus 450 may be retracted withinlumen 422 of sheath 420 via wires 424, even after anchor 470 hasdynamically expanded to the partially deployed configuration, forexample, to abort the procedure or to reposition sheath 420.

Once properly positioned, wires 424 a are retracted to expand skirtregion 474 of anchor 470 within left ventricle LV. Skirt region 474 islocked in the expanded configuration via skirt lock 490, as previouslydescribed with respect to FIG. 36. In FIG. 38A, skirt region 474 ismaneuvered such that it engages the patient's valve annulus An and/ornative valve leaflets L, thereby providing positive registration ofapparatus 450 relative to the anatomical landmarks.

Wires 424 b are then actuated external to the patient in order to expandlip region 472, as previously described in FIG. 35. Lip region 472 islocked in the expanded configuration via lip lock 480. Advantageously,deployment of apparatus 450 is fully reversible until lip lock 480and/or skirt lock 490 has been actuated. Wires 424 are pulled fromeyelets 483 and 493, and delivery system 410 is removed from thepatient. As will be apparent, the order of expansion of lip region 472and skirt region 474 may be reversed, concurrent, etc.

As seen in FIG. 38B, lip region 472 engages the patient's native valveleaflets L, thereby providing additional positive registration andreducing a risk of lip region 472 blocking the patient's coronary ostiaO. FIG. 38C illustrates the same in cross-sectional view, while alsoshowing the position of replacement valve 460. The patient's nativeleaflets are engaged and/or captured between lip region 472 and skirtregion 474. Advantageously, lip region 472 precludes distal migration ofapparatus 450, while skirt region 474 precludes proximal migration. Itis expected that lip region 472 and skirt region 474 also will reduceparavalvular regurgitation.

Referring now to FIG. 39, an embodiment of apparatus in accordance withthe present invention is described, wherein the replacement valve is notconnected to the expandable portion of the anchor. Rather, thereplacement valve is wrapped about an end of the anchor. Such wrappingmay be achieved, for example, by everting the valve during endovasculardeployment.

In FIG. 39, apparatus 500 comprises expandable anchor 30′ and evertingreplacement valve 520, as well as delivery system 100′ for endoluminallydelivering and deploying the expandable anchor and everting valve.Expandable anchor 30′ illustratively is described as substantially thesame as previously described anchor 30 of FIGS. 1-4; however, it shouldbe understood that anchor 30′ alternatively may be substantially thesame as anchor 300 of FIGS. 17 and 18, anchor 350 of FIGS. 24-26, oranchor 470 of FIG. 35. As with anchor 30, anchor 30′ comprises posts 38and locks (comprised of elements 523 and 532). Alternative locks may beprovided, such as locks 40′, 40″, 40′″ or 40″″ of FIGS. 11 and 12, orthe reversible lock of anchor 300 described with respect to FIGS. 17 and18.

Everting valve 520 is similar to previously described valve 20, in thatcommissures 524 of replacement valve leaflets 526 are coupled to andsupported by posts 38 of anchor 30′. However, annular base 522 ofreplacement valve 520 is not coupled to anchor 30′. Rather, annular base522 is coupled to everting segment 528 of everting replacement valve520. Everting segment 528 is disposed distal of anchor 30′ in thedelivery configuration and is configured to wrap about the distal end ofthe anchor during deployment, such as by everting, thereby holding (suchas by friction locking) replacement valve 520 between the anchor and thepatient's tissue, thereby creating a seal between the anchor and thepatient's tissue. In this manner, replacement valve 520 is entirelydisconnected from the expandable/collapsible portion of anchor 30′, anda delivery profile of apparatus 500 is reduced, as compared topreviously described apparatus 10.

Everting segment 528 of valve 520 may be fabricated from the samematerial as valve leaflets 526, e.g., a biologic tissue or a polymericmaterial. Alternatively, the segment may comprise a fabric, such as apermeable or impermeable fabric, a fabric that promotes or retardstissue ingrowth, a sealing foam, etc. Additional materials will beapparent.

Delivery system 100′ for use with anchor 30′ and replacement valve 520,is similar to previously described delivery system 100. The deliverysystem comprises sheath 110′-having lumen 112′, in which anchor 30′ maybe collapsed for delivery. Control wires 50, tubes 60 and control wires62 have been provided to deploy, foreshorten, retrieve, etc., anchor30′, as discussed previously, and optional balloon catheter 360 has beenprovided as a collapsible nosecone (see FIG. 25). In delivery system100′, the posts are connected to the distal end of the anchor and theeverting valve is connected to the posts. Delivery system 100′ differsfrom system 100 in that it further comprises eversion control wires 550,which may, for example, be fabricated from suture.

Control wires 550 are coupled to a distal region of everting segment 528of valve 520, and then pass proximally out of the patient external toanchor 30′ for manipulation by a medical practitioner. Control wires 550preferably are kept taut to keep everting segment 528 in tension. Uponretraction of sheath 110′ relative to anchor 30′ and valve 520 (oradvancement of the anchor and valve relative to the sheath), the tensionapplied to segment 528 by wires 550 causes the segment to evert and wrapabout the distal end of anchor 30′. Anchor 30′ then may be expanded anddeployed as described previously, thereby friction locking evertingsegment 528 between the anchor and the patient's anatomy.

FIG. 39 illustrate a device and method for endovascularly replacing apatient's diseased aortic valve utilizing apparatus 500. In FIG. 39A,sheath 110′ of delivery system 100′, having expandable anchor 30′ andeverting valve 520 disposed therein within lumen 112′, is endovascularlyadvanced over guide wire G, preferably in a retrograde fashion (althoughan antegrade or hybrid approach alternatively may be used), through apatient's aorta A to the patient's diseased aortic valve AV. Ballooncatheter nosecone 360 precedes sheath 110′. Sheath 110′ is positionedsuch that its distal region is disposed within left ventricle LV of thepatient's heart H. In FIG. 39A, wires 550 pass from segment 528 andlumen 112′ to the exterior of sheath 110′ via through-holes 111 a′, andthen more proximally pass back into the interior of sheath 110′ viathrough-holes 111 b′, which are disposed proximal of anchor 30′.

FIG. 39B is a blow-up of the intersection of tubes 60, wires 62 andanchor 30′.

FIG. 39C illustrates the beginning of the everting process whereineverting segment 528 is being pulled proximally over the exterior ofanchor 30′. As seen in FIG. 39C, which provides and isometric view ofthe device, the inflatable element of balloon catheter 360 is deflatedand further distally advanced within left ventricle LV along guide wireG relative to sheath 110′. Anchor 30′ and replacement valve 520 then areadvanced relative to the sheath via tubes 60 and control wires 62,thereby deploying everting segment 528 of valve 520, as well as a distalregion of anchor 30′, from the distal end of lumen 112′. Tension appliedto everting segment 528 via control wires 550 connected through eyelets529 causes the segment to wrap about the distal region of anchor 30′ byeverting.

In FIG. 39C, wires 550 may pass distally from everting segment 528 outthe distal end of lumen 112′ of sheath 110′, then proximally along theinterior surface of the sheath all the way out of the patient. Optionalthrough-holes 111 b′ allow wires 550 to be disposed within lumen 112′along a majority of their length. Wires 550 may also pass back intomulti-lumen sheath 180.

FIG. 39D provides a cross sectional view of apparatus 500 afterreplacement valve 520 has everted about anchor 30′. This and other crosssectional figures portray a 120° view of the apparatus herein. Sheath110′ is then retracted relative to anchor 30′ and valve 520, whichdeploys a remainder of the anchor and the replacement valve from lumen112′ of the sheath. Such deployment may be conducted, for example, underfluoroscopic guidance. Anchor 30′ dynamically self-expands to apartially deployed configuration.

Advantageously, anchor 30′ and replacement valve 520 may be retrievedand retracted within the lumen of sheath 110′ via retraction ofmulti-lumen catheter 180 to which tubes 60 are attached and release ofwires 50. Such retrieval of apparatus 500 may be achieved even aftersegment 528 has been wrapped about anchor 30′, and even after anchor 30′has dynamically expanded to the partially deployed configuration.Retrieval of apparatus 500 may be utilized, for example, to abort theprocedure or to reposition the apparatus. As yet another advantage,anchor 30′ and valve 520 may be dynamically repositioned, e.g. viaproximal retraction of multi-lumen catheter 180 and/or release of wires50, in order to properly align the apparatus relative to anatomicallandmarks, such as the patient's coronary ostia O or the patient'snative valve leaflets L.

Once properly aligned sheath 110′, tubes 60 and wires 62 are advancedrelative to wires 50 and 550 to impose foreshortening upon anchor 30′,thereby expanding the anchor to the fully deployed configuration, as inFIG. 39G. Foreshortening friction locks everting segment 528 of valve520 between anchor 30′ and annulus An/leaflets L of the patient'sdiseased valve, thus properly seating the valve within the anchor whileproviding an improved seal between the replacement and native valvesthat is expected to reduce paravalvular regurgitation. Foreshorteningalso increases a radial strength of anchor 30′, which is expected toprolong patency of valve annulus An. Furthermore, foreshorteningactuates the anchor's locks, which maintain such imposed foreshortening.

Deployment of anchor 30′ and replacement valve 520 advantageously isfully reversible until the anchor locks have been actuated. Furthermore,if the anchor's locks are reversible locks or buckles, such as thosedescribed in conjunction with anchor 300 of FIGS. 17 and 18, deploymentof the anchor and valve may be fully reversible even after actuation ofthe locks/buckles, right up until delivery system 100′ is decoupled fromthe replacement apparatus.

As seen in FIG. 39G, in order to complete deployment of anchor 30′ andreplacement valve 520, wires 50 of delivery system 100′ are decoupledfrom posts 38 of anchor 30′, tubes 60 are decoupled from anchor 30′,e.g. via wires 62, and wires 550 are decoupled from friction-lockedeverting segment 528 of replacement valve 520. FIG. 39E illustrates howwires 50 are associated with posts 38. In one example, wires 50 aredecoupled from posts 38 by pulling on one of the wires. Decoupling ofthe wires and tubes may also be achieved, for example, via eyelets (seeFIGS. 4E, 19-21 and 39E) or via cutting of the wires. Delivery system100′ then is removed from the patient, as are deflated balloon catheter360 and guide wire G, both of which are retracted proximally across thereplacement valve and anchor. Normal blood flow between left ventricleLV and aorta A thereafter is regulated by replacement valve 520. FIG.39F is a blow up illustration of replacement valves 526 which areconnected to everting segment 528, wherein everting segment 528 has beeneverted around anchor 30′.

Referring now to FIG. 40, an alternative embodiment of evertingapparatus in accordance with the present invention is described, whereinthe posts are connected and the everting valve is disposed within theanchor to the proximal end of the anchor in the delivery configuration.In FIG. 40, apparatus 600 comprises everting replacement valve 620 andanchor 630, as well as previously described delivery system 100′.Replacement valve 620 and anchor 630 are substantially the same as valve520 and anchor 30′ of FIG. 39, except that valve 620 is initially seatedmore proximally within anchor 630, such that everting segment 628 ofvalve 620 is initially disposed within the anchor. Locking mechanisms asdescribed previously may be implemented at the distal end of the postand anchor or proximal end of everted segment and anchor.

As with replacement valve 520, everting segment 628 of valve 620 isconfigured to wrap about the distal end of anchor 630 by everting duringdeployment, thereby friction locking the replacement valve between theanchor and the patient's anatomy. Furthermore, replacement valve 620 isentirely disconnected from the expandable/collapsible portion of anchor630. In the delivery configuration, since only a single circumferentiallayer of valve 620 is present along any cross section of apparatus 600,a delivery profile of the apparatus is reduced, as compared topreviously described apparatus 10. With apparatus 10, twocircumferential layers of valve 20 are present in the cross sectionwhere annular base 22 of the valve is coupled to the expandable anchor30.

FIG. 40 illustrate a method of endovascularly replacing a patient'sdiseased aortic valve utilizing apparatus 600. In FIG. 40A, apparatus600 is endovascularly advanced into position with valve 620 and anchor630 disposed within lumen 112′ of sheath 110′ of delivery system 100′.As seen in FIG. 40B, the valve and anchor are advanced relative to thesheath and/or the sheath is retracted relative to the valve and anchor,which deploys everting segment 628 of the valve, as well as a distalregion of the anchor. Tension applied to the everting segment viacontrol wires 550 causes the segment to evert and wrap about the distalregion of anchor 630. Control wires 550 may enter the multi-lumencatheter at the distal end of the catheter or more proximally as isillustrated in 40C. Further retraction of sheath 110′ deploys aremainder of replacement valve 620 and anchor 630 from lumen 112′ of thesheath. Such deployment may be conducted, for example, underfluoroscopic guidance. Anchor 630 dynamically self-expands to apartially deployed configuration.

Once the anchor and valve have been properly aligned in relation toanatomical landmarks, foreshortening is imposed upon anchor 630 toexpand the anchor to the fully deployed configuration, as in FIG. 40C.At this point, Locks may be actuated as previously described.Foreshortening friction locks everting segment 628 of valve 620 betweenanchor 630 and annulus An/leaflets L of the patient's diseased valve,thus properly seating the valve within the anchor while providing animproved seal between the replacement and native valves. Foreshorteningalso increases a radial strength of anchor 630, which is expected toprolong patency of valve annulus An. Deployed valve 620 and anchor 630then are decoupled from delivery system 100′, as in FIG. 40D, therebycompleting deployment of apparatus 600. Thereafter, normal blood flowbetween left ventricle LV and aorta A is regulated by replacement valve620.

As with apparatus 500, apparatus 600 may be dynamically repositionedduring deployment, for example, in order to properly align the apparatusrelative to anatomical landmarks. Furthermore, apparatus 600advantageously may be retrieved at any point at least up until actuationof optimal locks maintaining foreshortening. When the optional locks arereversible, retrieval may be achieved until valve 620 and anchor 630 areseparated from delivery system 100′.

FIG. 41 illustrate an alternative embodiment of the present inventionwherein the everting valve is distal to the anchor and the posts are notconnected to the braid in the delivery configuration. As is illustratedin FIG. 41A, apparatus 700 comprises everting valve 720 and expandableanchor 730, as well as delivery system 750. Delivery system 750 includesmulti-lumen catheter 180. Anchor 730 is fabricated from an expandablebraid and comprises female/male element 732 of a locking mechanism,which is preferably reversible. Everting valve 720 comprises valveleaflets 726 and everting segment 728. Everting valve 720 furthercomprises posts 722 to which valve leaflets 726 are attached to providecommissure support. Posts 722, which are non-expandable andnon-collapsible, comprise opposite male/female elements 723 of lockingmechanism comprising eyelets. In the delivery configuration of FIG. 41A,anchor 730 may extend distally far enough to just overlap theproximal-most section of valve 720.

Delivery system 750 is similar to previously described delivery system100′ and includes multi-lumen catheter 180. As with previousembodiments, delivery system 750 facilitates dynamic repositioningand/or retrieval of apparatus 700 after partial or full deployment ofthe apparatus, e.g., right up until the apparatus is separated from thedelivery system.

As seen in FIG. 41A, wires 50 pass from the multi-lumen catheter 180through the female/male locking mechanism 732, which is associated withanchor 730. Wires 50 then further pass through female/male lockingmechanism 723, which is at the proximal end of posts 722. Preferably, adouble strand of each wire 50 is provided to facilitate decoupling ofwires 50 from valve 720 and anchor 730 in the manner describedpreviously. When wires 50 are pulled proximally into the multi lumencatheter 180, posts 722 move proximally within anchor 730, and thefemale/male element 723 interacts with female/male element 732 of anchor730. In this embodiment, when element 723 is male, then element 732 isfemale, and vice versa.

Thus, valve 720 and anchor 730 are entirely decoupled from one anotherin the delivery configuration. Wires 50 are configured to approximatethe telescoped valve and anchor, as well as to actuate locking mechanism740 and contribute to foreshortening of anchor 730. By separating valve720 and anchor 730 within lumen 112′ of sheath 110′, a delivery profileof apparatus 700 may be reduced.

In FIG. 41A, apparatus 700 is endovascularly advanced into position withvalve 720 and anchor 730 spaced from one another within lumen 112′ ofsheath 110′ of delivery system 750. Substantially all of valve 720 andits supporting posts 722 are disposed distal to the anchor duringdelivery. As seen in FIG. 41B, to evert valve 720, sheath 110′ is pulledproximally around anchor 730.

Next, in FIG. 41C, to approximate anchor 730 and valve 720, theelongated braid of anchor 730 is pushed distally to the base of posts722 using tubes 60 maintained in association with anchor 730 by wire 62.Anchor 730 will engage with the distal end of posts 722—an anchorengagement feature 729. In some embodiments, as illustrated in FIG. 41C,wires 550 re-enter sheath 110′ proximal to the distal end of themulti-lumen catheter 180.

In FIG. 41D, the multi-lumen catheter 180 is held steady, while wires 50are pulled proximally. This allows the foreshortening of anchor 730 andthe engagement of the male and female elements of locking mechanism of740. Foreshortening friction locks segment 728 of valve 720 againstvalve annulus An/leaflets L, thereby properly seating the valve withinanchor 730. Foreshortening also completes expansion of anchor 730 andactuates locking mechanism 740, which maintains such expansion of theanchor. Delivery system 750 then may be decoupled from valve 720 andanchor 730, thereby completing deployment of apparatus 700. Normal bloodflow between left ventricle LV and aorta A thereafter is regulated byreplacement valve 720.

With reference now to FIG. 42, yet another alternative embodiment ofeverting apparatus in accordance with the present invention isdescribed, wherein the replacement valve leaflets evert and wrap aboutthe distal region of the anchor. Apparatus 800 comprises evertingreplacement valve 820 and expandable anchor 830. Valve 820 comprisesposts 822, to which valve leaflets 826 are attached. The valve furthercomprises everting segment 828. Proximal regions 823 of posts 822 arerotatably coupled to a distal region of anchor 830, while distal regions824 of the posts are coupled to control wires 50.

In the delivery configuration of FIG. 42A, posts 822 (and, thus, valveleaflets 826) and everting segment 828 of replacement valve 820 aredisposed distal of anchor 830. FIG. 42B illustrates deployment ofapparatus 800, whereby tubes 60/wires 62 (see, e.g., FIG. 41) areactuated in conjunction with control wires 50 to actively foreshortenanchor 830 and rotate posts 822 into position within the lumen of anchor830, thereby everting valve leaflets 826 into position within theanchor. Furthermore, eversion wires 550 are actuated to evert segment828 and wrap the segment about the exterior of anchor 830. Locks 840maintain expansion and foreshortening of anchor 830.

Referring to FIG. 43, an everting embodiment of the present invention isdescribed wherein a portion of the locking mechanism configured tomaintain expansion of the anchor is coupled to the everting segment ofthe replacement valve instead of, or in addition to, the anchor postsand anchor posts P are only loosely associated with the anchor 930.Apparatus 900 comprises replacement valve 920 and anchor 930. Evertingsegment 928 of the replacement valve comprises male elements 942 oflocks 940, while anchor 930 comprises female elements 944 of locks 940.Upon deployment of apparatus 900 from the delivery configuration of FIG.43A to the deployed configuration of FIG. 43B, segment 928 ofreplacement valve 920 everts to wrap about the exterior of anchor 930,which is actively foreshortened during expansion. Locks 940 maintainanchor expansion.

With reference to FIG. 44, another telescoping embodiment of the presentinvention is described wherein the replacement valve comprises aU-shaped frame configured to receive the anchor. Optionally, the valvemay comprise an everting segment that everts about the frame and/or theanchor during deployment. Apparatus 1000 comprises replacement valve1020 and expandable anchor 1030. Replacement valve 1020 comprises frame1022, leaflets 1026 and optional everting segment 1028.

Valve 1020 and anchor 1030 are configured for relative movement, suchthat the valve and anchor may be telescoped and spaced apart duringdelivery, thereby reducing a delivery profile of apparatus 1000, but maybe approximated during deployment. Everting segment 1028 of valve 1020optionally may be disposed distal of valve frame 1022 during delivery,thereby further reducing a delivery profile of apparatus 1000, theneverted during deployment.

As seen in FIG. 44A, the U-shape of valve frame 1022 preferably tiltsleaflets 1026 of replacement valve 1020 slightly inward relative toblood flow through apparatus 1000. As seen in FIG. 44B, valve frame 1022optionally may comprise a symmetric U-shape, which captures anchor 1030on both sides in the deployed configuration. Frame 1022 may compriselock 1040 that closes the frame's U-shape into an elliptical shape inthe deployed configuration, thereby maintaining expansion of anchor1030.

Prior to implantation of one of the replacement valves described above,it may be desirable to perform a valvuloplasty on the diseased valve byinserting a balloon into the valve and expanding it using saline mixedwith a contrast agent. In addition to preparing the valve site forimplant, fluoroscopic viewing of the valvuloplasty will help determinethe appropriate size of replacement valve implant to use.

1. A system for replacing a heart valve, comprising: an expandableanchor comprising a braided material, a replacement heart valve; and adelivery device, wherein the expandable anchor and the replacement heartvalve are adapted to be delivered within the delivery device to avicinity of a heart valve, and wherein the expandable anchor has adelivery configuration within the delivery device, wherein theexpandable anchor is axially spaced from the replacement heart valvewhen the expandable anchor is in the delivery configuration within thedelivery device.
 2. The system of claim 1 wherein the expandable anchorand the replacement heart valve are coupled to each other.
 3. The systemof claim 1 wherein the replacement heart valve is distally spaced fromthe expandable anchor when the expandable anchor is in the deliveryconfiguration within the delivery device.
 4. The system of claim 1wherein at least a portion of the replacement heart valve is disposedwithin the expandable anchor when the expandable anchor is in a fullydeployed configuration.
 5. The system of claim 4 wherein at least aportion of the replacement heart valve is disposed axially within theexpandable anchor when the expandable anchor is in the fully deployedconfiguration.
 6. A system for replacing a heart valve, comprising anexpandable anchor having a collapsed delivery configuration and anexpanded configuration; a replacement valve commissure support elementattached to the expandable anchor; a commissure portion of a replacementvalve leaflet attached to the commissure support element; and a seal atleast partially disposed around an exterior portion of the expandableanchor when the anchor is in the expanded configuration, wherein theseal is adapted to prevent blood from flowing between the seal and hearttissue, wherein a distal end of the replacement valve leaflet isattached to the seal.
 7. The system of claim 6 wherein the expandableanchor is not attached to the replacement valve leaflet.
 8. The systemof claim 6 wherein the distal end of the replacement valve leaflet isattached to a distal end of the seal when the expandable anchor is inthe expanded configuration.
 9. The system of claim 6 wherein thecommissure support element is configured to interface with an anchoractuator.
 10. The system of claim 9 wherein the anchor actuator isadapted to apply a proximally directed force on the commissure supportelement to foreshorten the expandable anchor.
 11. The system of claim 6further comprising a lock comprising a first lock element and a secondlock element, wherein the first and second lock elements are attached tothe expandable anchor and adapted to engage with one another to lock theexpandable anchor in the expanded configuration, and wherein thecommissure support element includes the first lock element.
 12. Thesystem of claim 11 wherein the second lock element is attached to theexpandable anchor and is disposed proximal to the first lock elementwhen the expandable anchor is in the collapsed configuration within adelivery catheter.